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NCT05947500 · ClinicalTrials.gov registry record · Phase 2

Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial

A Phase 2 study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
50
Enrollment target
20
Study locations

NCT05947500 is a Phase 2 study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, above the 27-participant average among 4 other Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 trials with a reported enrollment target (85% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT05947500, a Phase 2 study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial compares tuvusertib in combination with avelumab to tuvusertib alone to determine whether the combination therapy will lengthen the time before the cancer starts getting worse in patients with Merkel cell cancer that has not responded to previous treatment (refractory). Tuvusertib is a drug that inhibits an enzyme called ataxia telangiectasia and Rad3 related (ATR) kinase, which is an enzyme that plays a role in repair of damaged deoxyribonucleic acid (DNA) as well as tumor cell replication and survival. It may lead to tumor cell death by inhibiting ATR kinase activity. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tuvusertib in combination with avelumab may lengthen the time before Merkel cell cancer starts getting worse compared to giving avelumab alone.

Conditions Studied

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 Metastatic Merkel Cell Carcinoma Locally Advanced Merkel Cell Carcinoma Refractory Merkel Cell Carcinoma Unresectable Merkel Cell Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • DRUG Avelumab

Study Locations (20)

California

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • UC San Diego Moores Cancer Center - La Jolla
  • Keck Medicine of USC Koreatown - Los Angeles
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach - Newport Beach
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • Stanford Cancer Institute Palo Alto - Palo Alto

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall - Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
  • Moffitt Cancer Center - McKinley Campus - Tampa
  • Moffitt Cancer Center - Tampa

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Connecticut

  • Yale University - New Haven

District of Columbia

  • Sibley Memorial Hospital - Washington D.C.

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-05-21
Est. Completion 2028-01-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05947500

The ClinicalTrials.gov registry entry for NCT05947500 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 27-participant average among 4 other Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 trials with a reported enrollment target (85% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05947500 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT05947500 about?

NCT05947500 is a clinical study titled "Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial". This phase II trial compares tuvusertib in combination with avelumab to tuvusertib alone to determine whether the combination therapy will lengthen the time before the cancer starts getting worse in patients with Merkel cell cancer that has not responded to previous treatment (refractory). Tuvuserti...

What is the current status of trial NCT05947500?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-05-21. Estimated completion is 2028-01-01.

What conditions does trial NCT05947500 study?

This clinical trial studies the following conditions: Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Merkel Cell Carcinoma, Locally Advanced Merkel Cell Carcinoma, Refractory Merkel Cell Carcinoma.

What interventions are being tested in trial NCT05947500?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Avelumab (DRUG).

Who is sponsoring clinical trial NCT05947500?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05947500 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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